Supply issues reported as TGA tentatively approves Moderna for under-fives

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The Federal Minister of Health has urged parents to delay making appointments for the COVID vaccine for their very young children.

The Moderna pediatric vaccine is in short supply worldwide. (Image: AAP)


This article was updated on July 19 at 4:40 p.m. to include comments from the Federal Minister of Health and pediatrician specializing in infectious diseases, Professor Robert Booy.

Federal Health Minister Mark Butler has warned the public that Moderna’s pediatric vaccine is in short supply around the world, hours after it was provisionally approved by the Therapeutic Goods Administration (TGA) for use in Australian children aged six months to five years.


Despite the TGA’s endorsement, Minister Butler told reporters much remains to be done before the vaccine is available for very young children, including an assessment by the Australian Technical Advisory Group on Immunization (ATAGI).


“I want to emphasize again that the supply of this Moderna product is very limited, which is a different product from [those] made available to other age cohorts,” he said.


“As you can imagine, countries in North America, Europe and other parts of the world are competing fiercely to get their hands on this very limited supply.”


“My department is currently in active negotiations with Moderna to get Australia as many doses as possible.”


The TGA’s interim approval is the ‘first step’ towards the use of a COVID-19 vaccine in Australia, and indicates the regulator has judged it to meet high standards of safety, quality and efficacy .


The vaccine is the first to be approved for this age group in Australia, although it received a green light from the U.S. Food and Drug Administration (FDA) last month.


In light of global competition for supplies, Minister Butler has asked parents to delay booking their very young children for a COVID vaccine until further notice.


“There is no action yet that can be taken by parents … to make an appointment or otherwise,” he said.


“If I had one message for parents of children under five today, it’s to consider getting your child vaccinated against the flu.


“Our under-five flu vaccination rates are lagging behind what they have historically been at this point in the flu season – quite a considerable lag.”


Minister Butler added that of the approximately 1,300 Australians hospitalized with the flu this flu season, more than 700 were children under the age of 16.


Professor Robert Booy, a pediatrician specializing in infectious diseases and also head of the clinical research team at the National Center for Immunization Research and Monitoring, says the new vaccine is likely to be most beneficial for children with disabilities multiple, chronic medical conditions or immunodeficiency.


“It’s important to have a new, safe product that can be given to children as young as six months old,” he said.


“Very young children can also transmit infections they pick up in day care, to their vulnerable parents, teachers and vulnerable grandparents.


“Children who are otherwise well are unlikely to contract severe COVID-19, but with vaccination the risk decreases even further.”


Professor Booy also pointed out that safety reports from the United States – where the new vaccine has already been used in hundreds of thousands of children – are “reassuring”.


“The immune response to this vaccine in young children is very similar to the immune response in older children, adolescents and young adults, even though the dose given is lower,” he said.


“Use of the Moderna vaccine for young children is likely to be both safe and effective, and its implementation in Australia will contribute to better control of a disease that is proving difficult to manage.”


According to the TGA, Moderna’s pediatric vaccine is made in the same way as vaccines for the elderly, but contains a lower concentration of the active ingredient:

 

  • six months to less than five years – 25 mg in 0.25 ml vial
  • 6–11 years – 50 mg in 0.25 ml vial
  • 12 years and older – 100mg in 0.5ml vial

As with other age groups, the TGA said the vaccine will be given in two doses at least 28 days apart.

“As we have seen with children in older age groups, the TGA expects vaccines for young children to provide protection against the most severe consequences of COVID-19, such as hospitalization and death,” the statement read.

“In making this regulatory decision, the TGA carefully reviewed data from the KidCOVE clinical trial, which was conducted at multiple sites in Canada and the United States and included more than 6,000 participants aged six months to six years.

“The study demonstrated that the immune response to the vaccine in children was similar to that seen in young adults. [18–25 years] with a favorable safety profile.

The TGA said most of the adverse events seen in clinical trials for this cohort were mild to moderate and usually reported after the second dose. Adverse events included irritability/crying, redness and/or swelling at the injection site, fatigue, fever, muscle aches, and axillary (groin) swelling or tenderness.

The tentative approval of this vaccine in this age group is valid for two years and subject to certain strict conditions, such as the obligation for Moderna to continue to provide information to the TGA on efficacy and safety at more long-term ongoing clinical trials and post-marketing evaluation.

“Australians can be confident that the TGA’s review process for this vaccine was rigorous and of the highest standard,” the regulator said.

“The decision to tentatively approve the vaccine was also informed by expert advice from the Vaccine Advisory Committee, an independent committee specializing in scientific, medical and clinical areas, including consumer representation.

“The TGA will continue to actively monitor the safety of the vaccine in children and adults both in Australia and in collaboration with our overseas counterparts. If security issues are identified, we will take action and promptly provide information to the public.

The TGA will publish Australia’s public assessment report regarding its interim approval of the Moderna pediatric vaccine “in the coming days”.

Pfizer also recently began the process of applying for permission to use its own COVID-19 vaccine among Australia’s youngest age cohort.

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